Needle safety device

ABSTRACT

The invention relates to a needle safety device for a medical device, the needle safety device comprising: a base portion having a bore extending along a longitudinal center axis therethrough for receiving a needle; and two opposing jaws extending from the base portion generally in the axial direction and each having a head portion in the region of its free end, wherein the needle safety device includes a locking projection for securing the needle safety device to the medical device. The needle safety device according to the invention further provides at least one elastic element mounted to the jaws in a non-surrounding manner lateral to the center axis in a region between the base portion and the head portions, wherein at least one elastic element and the jaws are configured such that the jaws can be spread apart against a restoring force of at least one elastic element in order to allow the needle received in the bore to extend all the way through the needle safety device.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/237,657 filed on Feb. 7, 2014, which is the national phase ofInternational Application No. PCT/IB2012/054034 filed on Aug. 8, 2012,which claims priority from Indian Provisional Patent Application No.2330/DEL/2011 dated Aug. 9, 2011, the entire disclosures of which areincorporated herein by reference.

The present invention relates to a needle safety device for a medicaldevice such as, for example, an intravenous catheter apparatus, a baseportion having a bore extending along a longitudinal center axistherethrough for receiving a needle; and two opposing jaws extendingfrom the base portion generally in the axial direction and each having ahead portion in the region of its free end, wherein the needle safetydevice includes a locking projection for securing the needle safetydevice to the medical device.

A needle safety device of this kind is generally known and operative asa guard for the tip of a needle of the medical device by automaticallycovering the needle tip during withdrawal of the needle from a patient.The needle safety device thereby serves to prevent accidental prickingof for example, a medical professional by the needle after removal ofthe needle from the medical device.

In the prior art document EP 2 016 963 B1 a corresponding needle safetydevice is disclosed. This corresponding safety device has an annularresilient member surrounding the two jaws in a ring-like fashion.Although this needle safety device has a reliable functioning, it can beimproved and simplified in regard to its structure.

It is an object of the invention to provide a needle safety device whichprovides a reliable protection against accidental pricking by the needleand which has a simple structure.

This object is satisfied by a needle safety device having the featuresof claim 1.

The needle safety device of the invention is characterized by at leastone elastic element mounted to the jaws in a non-surrounding mannerlateral to the center axis in a region between the base portion and thehead portions, wherein the at least one elastic element and the jaws areconfigured such that the jaws can be spread apart against a restoringforce of the at least one elastic element in order to allow the needlereceived in the bore to extend all the way through the needle safetydevice.

Due to the at least one elastic element exerting its restoring force onthe jaws in the spread apart state of the jaws, which is the state inwhich the medical device, for example, an intravenous catheterapparatus, is typically shelved prior to use, the at least one elasticelement ensures that the spread apart jaws will snap together and guardthe needle tip upon withdrawal of the needle from the medical deviceeven after a longer shelf time, thereby continuously ensuring a correctfunctioning of the needle safety device. In addition, the at least oneelastic element prevents the jaws from becoming loose when the needlesafety device slides along the needle, thereby further aiding a correctfunctioning of the needle safety device.

As a result of the at least one elastic element being arranged in aregion between the base portion and the head portions of the jaws, theat least one elastic element also helps prevent the needle tip fromprotruding sideways out of the needle safety device, thereby furtherincreasing the protecting function of the needle safety device.

Furthermore, due to the arrangement of the at least one elastic elementbetween the base portion and the head portions of the jaws, a lockingrecess for receiving a locking protrusion formed inside the housing ofthe medical device is formed between the elastic element and the lockingshoulder of the at least one head portion. When the locking protrusionengages with the recess formed by the shoulder of the at least one headportion and the at least one elastic element, the needle safety deviceis safely secured inside the housing of the medical device and is, inparticular, prevented from in the axial direction relative to thehousing.

In contrast to the above-mentioned prior art, the at least one elasticelement does not surround the needle safety device. Instead, the atleast one elastic element is mounted to the jaws such that it biases thejaws to one another by means of the restoration force. Preferably the atleast one elastic element is integrally fixed to the jaws such that itcannot be moved or lost or inappropriately positioned on the needlesafety device in use or during manufacturing.

According to one embodiment, the at least one elastic element providessaid restoring force substantially in axial direction. In other words,the at least one elastic element is drawn or tensioned substantiallyalong the direction of the longitudinal center axis of the needle safetydevice, i.e. along the needle shaft when the needle shaft extendsthrough the space between the two jaws and spreads the jaws under therestoration force of the at least one elastic element.

According to an alternative embodiment, the at least one elastic elementprovides said restoring force transverse to said axial direction. Inthis alternative embodiment, the at least one elastic element is drawnor tensioned substantially transverse to the direction of thelongitudinal center axis of the needle safety device, i.e. in thedirection transverse to the needle shaft when the needle shaft extendsthrough the space between the two jaws and spreads the jaws apartagainst the restoration force of the at least one elastic element.

In a further embodiment, the two different kinds of elastic elements canbe combined, e.g. by using one elastic element providing its restorationforce transverse to said axial direction on one side of the needle shaftand providing its restoration force substantially along the axialdirection on the other side of the needle shaft.

The at least one elastic element can be adapted to form a partialsidewall such that together with the jaws it defines a chamber insidethe needle safety device, in which the needle tip is held after completewithdrawal of the needle from the medical device, thereby furtherincreasing the guarding function of the needle safety device.

The axial dimension of the at least one elastic element may range fromabout one fifth of the length of the jaws to about two thirds or threefourths of the length of the jaws, and preferably is in the range ofabout one third of the length of the jaws.

Preferably, the at least one elastic element is made from a materialhaving elastic properties, for example, an elastic material such asrubber, silicone or the like. Due to its elastic properties, the elasticelement creates a restoring force on the jaws, when the needle fullyextends through the needle safety device thereby spreading the jawsapart and expanding the elastic element. As soon as the needle tippasses the free ends of the jaws upon pulling the needle through theneedle safety device, the jaws are positively collapsed by the elasticelement due to its restoring force. As described below, it can also beformed by a metal spring. For example, the at least one elastic elementcomprises a tension ring or tension strip or tension spring mounted tothe jaws, respectively.

In accordance with a further embodiment, the jaws are connected to eachother by at least one link in a region between the base portion and thehead portions. Preferably, the link is arranged in the region of theelastic element. The link may be provided on only one side of the jaws.Alternatively, first and second links may be provided on opposite sidesof the jaws.

Preferably, the at least one link is formed to have spring-likeproperties such that the jaws can be spread apart against a restoringforce of the link. For example, the link may have a curved shape, suchas an S- or Z-like shape. Alternatively, the link may have asubstantially straight shape.

The at least one link prevents the two jaws from spreading apart toofar, thus preventing over-stretching of the elastic element which couldresult in a loss of elastic properties. Furthermore, the link supportsthe elastic element in exerting a force on the jaws in the collapsingdirection, thereby aiding the elastic element in preventing the jawsfrom becoming loose when the needle safety device slides along theneedle. In addition, the link causes the jaws to collapse even if theelastic element should fail in its function. The link is designed suchthat it retains its spring-like properties over the period of shelflive.

To allow for a simplified and cost-effective production of the needlesafety device, the base portion, the jaws, the elastic element andpreferably also the at least one link may be integrally formed andpreferably made from a plastic material, for example, by injectionmolding. Alternatively, the base portion, the jaws, and preferably alsothe at least one link may be made from a metal material. According to afurther embodiment, the base portion, the jaws and/or the link eachcomprise a different material or combination of materials, such as adifferent plastic material, a different metal material or a differentcombination of plastic and/or metal materials. For example, the base maybe made from a metal material and the jaws may be made from a plasticmaterial, or vice versa. It is also considered that the inner part ofthe jaws, which contacts the needle, is made from a thermoplasticmaterial such as TPE, whereas the outer part of the jaws may be madefrom a different material, for example, a plastic, metal, composite orelastomer material, so that the needle safety device causes lessfriction when sliding along the needle thereby facilitating thewithdrawal of the needle. The elastic element can be formed of any kindof rubber material.

In regard to the further structure of the needle safety device accordingto the present invention, it is possible according to one embodimentthat the tension ring is mounted to mounting features provided on eachof the jaws. In particular, in this embodiment of the invention it canbe provided that the mounting features comprise mounting projections,mounting hooks, mounting recesses or the like. This means that thetension ring is hooked onto the particular mounting features and biasedtherebetween.

As an alternative, it is possible that the tension strip is integrallyfixed with its ends to the jaws, in particular by using an adhesive orby co-molding. In other words, the tension strip is fixedly connectedwith it ends to each of the jaws and connects the jaws such that thetension strip is biased as soon as the jaws are spread by the needleshaft.

According to a still further embodiment, it can be provided that tensionspring is formed by a coil spring fixed with its ends to each of thejaws, respectively. The coil spring is extended against its restorationforce when the jaws are spread by the needle shaft.

Generally, it is possible that only one elastic element is provided ononly one side of the jaws. As long as the elastic element is strongenough to provide sufficient restoration force to the jaws, only oneelastic element is sufficient. Preferably in order to increase thereliability of the needle safety device according to the presentinvention first and second elastic elements are provided on oppositesides of the jaws.

In order to prevent the needle tip guarded by the needle safety devicefrom protruding beyond the free ends of the jaws, at least one of thejaws has an angled end section at its free end, which extends towardsthe other one of the jaws in a direction generally perpendicular to theaxial direction.

Preferably, the length of the at least one angled end section isselected such that the angled end section is supported on the needlewhen the needle extends all the way through the needle safety device,thereby spreading the jaws apart far enough for the shoulder of the headportion of the jaw having the angled end section to be able to engagebehind the locking protrusion provided in the housing of the medicaldevice.

The needle safety device according to the present invention as mentionedabove has a locking projection for securing the needle safety device tothe medical device. This locking projection can be formed by aprojection which interacts with a corresponding recess or projection inthe interior of the medical device, e.g. a catheter hub, which receivesthe needle safety device. On the other hand, according to an alternativeembodiment of the present invention, the locking projection may beformed on an additional arm provided at the needle safety device whichinteracts with the outside surface of the medical device, e.g. thecatheter hub.

Further subject matter of the invention is a needle for a medical devicesuch as, for example, an intravenous catheter apparatus, which has aninner profile, i.e. cross-section area defined by the inner periphery orcircumference of the needle, a principal outer profile, i.e. principalcross-section area defined by the outer periphery or circumference ofthe needle, and a needle tip, the needle further comprising at least oneenlargement in the region of the needle tip, wherein the enlargement isformed from an increase of the outer profile, whereas the inner profileremains substantially unchanged.

Still further subject matter of the invention is a medical device, inparticular an intravenous catheter apparatus, comprising a needle of theaforementioned type and a needle safety device, in particular of theabove described kind, which is slidably arranged on the needle forprotecting the needle tip, wherein the needle safety device includes abase portion having a bore extending therethrough for receiving theneedle, the bore being adapted to the principal outer profile of theneedle.

The enlargement and thus increase in effective diameter in the region ofthe needle tip prevents the needle tip from being pulled through thebase portion of the needle safety device during withdrawal of the needlefrom the medical device. In other words the enlargement prevents theneedle safety device from sliding beyond the needle tip and thus ensuresthat the needle tip is continuously and reliably guarded by the needlesafety device after removal of the needle from the medical device.

By forming the enlargement such that only the outer profile of theneedle is increased, whereas the inner profile remains unchanged, inother words by maintaining a substantially constant inner cross-sectionarea throughout the entire length of the needle, blood from a patiententering the needle can freely flow along the inside of the needle. Inother words a flashback of blood, which occurs when the needlepenetrates a vein, is not adversely affected by the enlargement.

The enlargement may be formed by subjecting the needle to concentratedheat at a localized area using, for example, a welding process such as alaser welding process, with or without addition of additional material.

Alternatively, the enlargement may be formed from additional materialdispensed onto the outer surface of the needle. In order to locate thedispensed material in a defined position, a recess or groove may beformed in the outer surface or circumference of the needle.

The additional material may, for example, be selected from at least oneof a plastic material, an adhesive, a resin and a metal material.

In the case of the additional material being a metal material, theenlargement may, for example, be formed by build-up welding of theadditional material onto the needle.

Preferred embodiments of the invention are described in the followingdescription and in the accompanying drawings, wherein:

FIG. 1 shows a view partly in cross-section of a wing housing of anintravenous catheter apparatus, including a needle safety deviceaccording to a first embodiment of the invention inserted therein and aneedle extending therethrough;

FIG. 2 shows a view partly in cross-section of the wing housing of FIG.1, including the needle safety device, but not the needle;

FIG. 3 shows a side view of a second embodiment of the needle safetydevice including a tension strip biased in a direction transverse to thelongitudinal direction;

FIG. 4 shows a side view of a third embodiment of the needle safetydevice including a tension strip biased substantially in longitudinaldirection;

FIG. 5 shows a side view of a fourth embodiment of the needle safetydevice including a tension ring biased substantially in longitudinaldirection;

FIG. 6 shows a side view of a fifth embodiment of the needle safetydevice including a tension spring biased substantially in longitudinaldirection;

FIG. 7 shows a plan view of the wing housing of FIG. 1;

FIG. 8A shows a cross-sectional view of a section of the wing housing ofFIG. 7 detailing an annular locking protrusion;

FIG. 8B shows a cross-sectional view of a section of the wing housing ofFIG. 7 detailing an alternative embodiment of the annular lockingprotrusion;

FIG. 9A shows a side view of the needle tip region of the needle of FIG.1 showing the details of an enlargement formed on the outer surface ofthe needle;

FIG. 9B shows a plan view of the needle tip region of FIG. 9A;

FIG. 10 shows a cross-sectional view of the needle of FIG. 9 in theregion of the enlargement which has been formed by welding; and

FIG. 11 shows cross-sectional views of the needle of FIG. 9 in theregion of the enlargement, illustrating the formation of the enlargementby a deposition process.

Referring to FIG. 1, a catheter hub or wing housing 10 of an intravenouscatheter apparatus is shown. The wing housing 10 comprises a main body12 of generally tubular form and extending in an axial direction. Themain body has a distal end 14 and a proximal end 16. A catheter 17 (FIG.7) is attached to the main body 12 at the distal end 14 of the main body12. A port 18 extends from the main body 12 in a direction generallyperpendicular to the axial direction. Wings 20 (FIG. 7) are provided atthe main body 12 opposite from the port 18. The main body 12 defines achamber 22 extending from the proximal end 16 towards the distal end 14.

Prior to use of the intravenous catheter apparatus, a needle 24 extendsthrough the wing housing 10 in the axial direction. The needle 24 has aninner profile, i.e. cross-section area defined by the inner periphery orcircumference of the needle 24, which is substantially constant acrossthe length of the needle 24. A principal outer profile, i.e. principalcross section area defined by the outer periphery or circumference ofthe needle 24, is also substantially constant across the length of theneedle 24 except for an enlargement 26 of the needle 24 provided in theregion of the needle tip at the distal end of the needle 24, which willbe described in more detail below with reference to FIGS. 9 to 11.

Still referring to FIG. 1, a needle safety device 28 is slideablyarranged on the needle 24. Prior to use of the intravenous catheterapparatus, the needle safety device 28 is inserted into the chamber 22from the proximal end 16 of the main body 12.

As can be seen from FIGS. 1 and 2, the needle safety device 28 comprisesa base portion 30 which has a bore extending in the axial directiontherethrough for receiving the needle 24. The bore is matched in shapeand size to the principal outer profile of the needle 24. The bore canbe reinforced with an additional member, like a metal washer, a sleeveor the like. There can also be provided a sleeve on the needle shafthaving a larger outer diameter than the bore in the base portion 30.

First and second jaws 34, 36 extend from the base portion 30 generallyin the axial direction. The first jaw 34 has a first head portion 38 inthe region of its free end, and the second jaw 36 has a second headportion 40 in the region of its free end. The first head portion 38extends beyond the second head portion 40 and has an angled end section42 at its free end, which extends towards the second jaw 36 in adirection generally perpendicular to the axial direction.

The length of the angled end section 42 is selected such that the angledend section 42 protrudes over at least a part of the second head portion40, when the jaws 34, 36 are in a relaxed position as is shown in FIGS.2 to 6. When the needle 24 extends all the way through the needle safetydevice 28, such as prior to use of the intravenous catheter device asshown in FIG. 1, the angled end section 42 is supported on the needle24, whereby the first jaw 34 is forced away from the second jaw 36 fromits relaxed position into a spread apart position.

In the embodiment according to FIGS. 1 and 2 the jaws 34, 36 areconnected by two tension strips 44 (only one shown) in a region betweenthe base portion 30 and the head portions 38, 40. The tension strips 44are made from an elastic material, such as rubber, silicone or the like.The tension strips 44 are fixed with their end portions 45, 47 to twoopposite sides of the jaws 34, 36, i.e. by using an adhesive or bymolding these tensions strips integrally onto the jaws 34, 36. Thetension strips 44 exert a restoring force on the jaws 34, 36, when thejaws are spread apart by the needle 24, as shown in FIG. 1. There is noadditional elastic member surrounding the needle safety device 28, likea rubber ring or the like.

As is illustrated in FIGS. 1, 2 and 3, the tension strips 44 cover asubstantial part of the jaws 34, 36 seen in the axial direction.Specifically, the axial dimension of the tension ring may range fromabout one fifth of the length of the jaws to about two thirds or threefourth of the length of the jaws, and preferably is in the range ofabout one third of the length of the jaws.

As can be seen from FIGS. 1 and 2, the jaws 34, 36 are slightly angledtowards each other in the region of the tension strips 44, resulting inthe outer profile of the needle safety device 28 being tapered towardsthe head portions 38, 40.

Two part annular protrusions 48 are formed on the outer surface of thejaws 34, 36, as shown in FIGS. 1 and 2. It is to be noted that the partannular protrusions 48 are optional, i.e. the needle safety device 28can also be made without any part annular protrusions.

As can be seen from FIGS. 1 and 2, a locking shoulder 50 is formed atthe side of each head portion 38, 40 facing the tension ring 44. Thelocking shoulder 50 and the tension ring 44 together form a recess orgroove 52.

Referring again to FIG. 1, an annular locking protrusion 54 is formed onthe inner surface of the main body 12 of the wing housing 10 andprotrudes into the chamber 22.

Prior to use of the intravenous catheter apparatus, i.e. when the needlesafety device 28 is inserted into the chamber 22 and the needle 24extends all the way through the needle safety device 28 and the winghousing 10, the annular locking protrusion 54 is received in the recess52 defined by the tension ring 44 and the head portion 38 of the firstjaw 34, which is forced away from the second jaw 36 due to the angledend section 42 supported on the needle 24.

Because of the annular locking protrusion 54 engaging into the recess 52of the needle safety device 28 in the spread apart state of the jaws 34,36, the needle safety device 28 is secured against movement relative tothe main body 12 in the axial direction. Specifically, the needle safetydevice 28 cannot be pulled out of the wing housing 10, since the lockingshoulder 50 of the head portion 38 of the first jaw 34 engages behindthe annular locking protrusion 54.

As is illustrated in FIG. 7, the annular locking protrusion 54 is adistance away from the proximal end 16 of the main body 12, thisdistance being in the range of 5 mm to 6 mm or more.

The annular locking protrusion 54 may have a substantially rectangularprofile with rounded edges (FIG. 8A), a rounded profile similar to aGaussian curve or a semi-sinusoidal curve (FIG. 8B) or any other profilesuitable for locking of the needle safety device 28 in the wing housing10.

Preferably, the locking protrusion 54 is of continuous annular shape.However, it is generally also possible to consider an annular lockingprotrusion 54 having one or more interruptions.

When the needle 24 is being withdrawn from a patient and, thus, from theintravenous catheter apparatus, the needle 24 is simultaneously pulledthrough the needle safety device 28. As has been mentioned above, aslong as the jaws 34, 36 are in their spread apart position, the needlesafety device 28 is secured against axial movement relative to the mainbody 12, i.e. the needle safety device 28 remains in the wing housing10.

However, as soon as the tip 56 of the needle 24 moves into the needlesafety device 28, i.e. passes beyond the angled end section 42 of thefirst jaw 34, the first jaw 34 snaps back or collapses into its relaxedposition, as shown in FIG. 2, due to the restoring force exerted by thetension strip 44.

When the first jaw 34 adopts its relaxed position, the lockingprotrusion 54 is released from the recess 52 and the locking shoulder 50of the first head portion 38 is disengaged from the locking protrusion54. As a result, the safety device 28 is free to move relative to themain body 12 in the axial direction. Specifically, the needle safetydevice 2S can now be pulled out of the wing housing 10, as is indicatedin FIG. 2.

As is illustrated in FIG. 9, the position of the enlargement 26 formedon the outer surface of the needle 24 is selected such that theenlargement 26 abuts the base portion 30 of the needle safety device 28as soon as the needle tip 56 has passed the free end of the second jaw36.

Since the maximum outer dimension of the needle 24 in the region of theenlargement 26 is larger than the dimension of the bore in the baseportion 30, which is adapted to the principal outer profile orcircumference of the needle 24, the needle 24 cannot be further pulledout of the needle safety device 28. In other words, because of theenlargement 26, the needle safety device 28 cannot slide off the needle24 during normal use of the needle 24 and needle safety device 28, i.e.unless an excessive external force is applied to the needle 24 and/orthe needle safety device 28.

With the needle tip 56 captured inside the needle safety device 28, theneedle tip 56 is covered by the angled end section 42 of the first jaw34. At the same time, the tension strips 44 prevent the needle tip 56from coming sideways out of the needle safety device 28. Hence, theneedle tip 56 is safely guarded by the needle safety device 28.

Referring to FIGS. 10 and 11, the enlargement 26 of the needle 24 isformed such that the inner profile of the needle 24 is not affected bythe formation of the enlargement 26, i.e. remains substantiallyunchanged. Thereby, when the needle 24 penetrates a vein, the flow ofblood through the needle 24 will not be adversely affected by theenlargement 26.

The enlargement 26 may be formed as a bump by subjecting the needle 24to concentrated heat at a localized area, for example, using a weldingprocess, such as a build-up welding process or a laser welding process,with or without addition of additional material (FIG. 10).

Alternatively, the enlargement 26 may be formed by dispensing additionalmaterial 58 onto the outer surface of the needle 24, such as anadhesive, a resin or a metal material. The additional material 58 may beplaced in a recess 60 which has been formed in the outer surface of theneedle 24 prior to dispensing the additional material 58. However,formation of the recess 60 is optional.

Although only one enlargement 26 is shown in FIGS. 9 to 11, it is to benoted that more than one enlargement may be present on the outer surfaceof the needle 24.

Referring to FIG. 3 a second embodiment is shown, wherein the needlesafety device 28 is depicted in a relaxed state without the needle) andwith a different kind of base portion 30. The base portion includes twoarms and 29, 31, wherein the first arm 29 has a shorter extent in axialdirection entering the second arm 31 has a larger extent in axialdirection. At the free end of the second arm 31 a locking protrusion 33is integrally formed with the second arm 31 which is provided tointeract with a corresponding recess or projection at the outsidesurface of the wing housing (not shown). Thereby, the needle safetydevice can be held in position in regard to the wing housing when theneedle is been retracted as described above. As soon as the enlargement26 of the needle comes into contact with the base portion 30, the needlesafety device can be retracted from the wing housing by overcoming theresistance and dissolving the interaction between the locking protrusion33 and the corresponding feature on the outside surface of the winghousing.

The embodiment according to FIG. 3 also has two tension strips 44 fixed36 by co-molding with their end portions 45, 47 to the two jaws 34, forbiasing the jaws 34, 36 as described above.

FIG. 4 shows a further embodiment including two tension strips 44. Theshape and structure of the needle safety device 28 is similar to theembodiment according to FIG. 3. However, the tension strips 44 of thisembodiment are fixed by co-molding with their end portions 45, 47 to thehead portions 38, 40 of the two jaws 34, 36 such that the tension strips44 are biased substantially in longitudinal direction. In other words,as shown in FIG. 4 the tension strips 44 run in longitudinal directionin the relaxed state, i.e. along the longitudinal center axis of theneedle safety device 28. When the jaws 34, 36 are spread apart due tothe needle shaft extending therebetween (not shown), of the tensionstrips 44 are stretched and run inclined to the longitudinal centeraxis.

FIG. 5 shows a further embodiment including two tension rings 44. Thetension rings 44 are annular elements, e.g. 0-rings, formed from elasticmaterial such as rubber or the like. On each head portion 38, 40 of thetwo jaws 34, 36 hook-like projections 51, 53 are integrally formed,which protrude from the needle safety device 28 in lateral oppositedirections. The tension rings 44 are hooked on these projections 51, 53and biased there between. The functioning is similar to that of thetension strips 44 shown in FIG. 4.

FIG. 6 shows a further embodiment including at least one tension spring44. The tension spring 44 is fixed with its end portions 45, 47 toopposite sides 37, 39 of the two head portions 36, 38 of the two jaws34, 36. The tension spring 44 is formed as the coil spring which isstretched and expanded against a restoration force when the two jaws 34,36 are spread by the needle shaft extending therebetween (not shown).The fixation of the end portions 45, 46 of the tension spring 44 on theopposite surfaces 37, 39 can be achieved by press-fitting the endportions 45, 47 into corresponding recesses in these surfaces 37, 39, byhook-like connections, by using an adhesive the end portions or bycombinations thereof.

REFERENCE NUMERAL LIST

-   10: wing housing-   12: main body-   14: distal end-   16: proximal end-   17: catheter-   18: port-   20: wing-   22: chamber-   24: needle-   26: enlargement-   28: needle safety device-   29: side arm-   30: base portion-   31: side arm-   32: locking projection-   34: first jaw-   36: second jaw-   37: surface-   38: head portion-   39: surface-   40: head portion-   42: angled end section-   44: tension strip, tension ring, tension spring-   45: end portion-   46: link-   47: end portion-   48: annular protrusion-   50: locking shoulder-   51: hook-like protrusion-   52: recess-   53: hook-like protrusion-   54: locking protrusion-   56: needle tip-   58: additional material-   60: recess

What is claimed is:
 1. A needle safety device for a medical device, theneedle safety device comprising: a base portion having a bore extendingalong a longitudinal center axis therethrough for receiving a needlehaving a needle tip and a needle shaft; two opposing jaws extending fromthe base portion generally in the axial direction and each having a headportion in the region of its free end, wherein a projection extendsoutwardly from the head portion of one of said jaws; and an elasticelement constructed separate from the jaws and configured to be mountedon the projection extending outwardly from the head portion of the oneof said jaws and connected to the head portion of the other of saidjaws, wherein the needle safety device includes a locking projection forsecuring the needle safety device to the medical device, wherein theelastic element and the jaws are configured such that the jaws arecapable of being spread apart against a restoring force of the elasticelement that is provided in an axial direction on one side of the needleshaft, and also providing a restoring force transverse to the axialdirection on another side of the needle shaft in order to hold theneedle tip within the needle safety device as the needle is pulledthrough the needle safety device, and wherein the transverse forceand/or the axial force is also provided on the jaws when the needle isnot within the needle safety device.
 2. The needle safety device inaccordance with claim 1, wherein the elastic element comprises rubber orsilicone.
 3. The needle safety device in accordance with claim 1,wherein the elastic element comprises a tension ring or tension strip ortension spring mounted to the jaws, respectively.
 4. The needle safetydevice in accordance with claim 3, wherein the tension ring is mountedto a mounting structure provided on each of the jaws.
 5. The needlesafety device in accordance with claim 4, wherein the mounting structurecomprises a projection, a hook, and/or a mounting recess.
 6. The needlesafety device in accordance with claim 1, wherein the elastic elementcomprises an elastic ring mounted on one side of each of the jaws. 7.The needle safety device in accordance with claim 1, wherein only oneelastic element is provided on only one side of the jaws.
 8. The needlesafety device in accordance with claim 1, wherein the elastic elementcomprises an elastic ring connected to extensions extending in atransverse axial direction from a side of the jaws.
 9. The needle safetydevice in accordance with claim 1, wherein at least one of the jaws hasan angled end section at its free end, which extends towards the otherone of the jaws in a direction generally perpendicular to the axialdirection.
 10. An intravenous catheter apparatus comprising: a needlehaving a needle tip; and a needle safety device in accordance with claim1, slidably arranged on the needle for protecting the needle tip,wherein the bore of the needle safety device is adapted to a principalouter profile of the needle.
 11. An intravenous catheter apparatus inaccordance with claim 10, wherein a locking protrusion for engaging withthe needle safety device is formed on an inner or outer surface of acatheter hub of the intravenous catheter apparatus.
 12. The intravenouscatheter apparatus in accordance with claim 11, wherein said lockingprotrusion is annular.
 13. The intravenous catheter apparatus inaccordance with claim 11, wherein a length of an angled end section isselected such that the angled end section is supported on the needlewhen the needle extends all the way through the needle safety device,thereby spreading the jaws apart far enough for a shoulder of the headportion of the jaw having the angled end section to engage with ahousing of the medical device for securing the needle safety device inthe housing.
 14. The safety device of claim 1, wherein said elasticelement acts alone in providing said restoring force to the jaws duringnormal operation.
 15. A needle safety device for a medical device, theneedle safety device comprising: a base portion having a bore extendingalong a longitudinal center axis therethrough for receiving a needlehaving a needle tip and a needle shaft; two opposing jaws extending fromthe base portion generally in the axial direction and each having a headportion in the region of its free end; and an elastic elementconstructed separate from the jaws and configured to be mounted on thejaws, wherein the needle safety device includes a locking projection forsecuring the needle safety device to the medical device, wherein theelastic element and the jaws are configured such that the jaws arecapable of being spread apart against a restoring force of the elasticelement that is provided in an axial direction on one side of the needleshaft, and also providing a restoring force transverse to the axialdirection on another side of the needle shaft in order to hold theneedle tip within the needle safety device as the needle is pulledthrough the needle safety device, and wherein the transverse forceand/or the axial force is also provided on the jaws when the needle isnot within the needle safety device, and wherein the elastic elementcomprises a coil spring mounted on an end of one of the jaws.
 16. Theneedle safety device in accordance with claim 15, wherein the coilspring has ends fixed to opposing surfaces of each of the jaws,respectively.
 17. A needle safety device for a medical device, theneedle safety device comprising: a base portion having a bore extendingalong a longitudinal center axis therethrough for receiving a needle;two opposing jaws extending from the base portion generally in the axialdirection and each having a head portion in the region of its free endand; an elastic element constructed separate from the jaws andconfigured to be connected to an end or to a projection extending fromthe end of one of the jaws, wherein the needle safety device includes alocking projection for securing the needle safety device to the medicaldevice, wherein the elastic element is a separate component comprising amaterial different than the material comprising the jaws that is mountedand secured to an outer surface of the jaws or to a part protrudingtherefrom, said elastic element being arranged with the jaws in anon-surrounding manner lateral to the center axis in a region betweenthe base portion and the head portions, wherein the elastic element andthe jaws are configured such that the jaws are capable of being spreadapart against a restoring force of the elastic element that is providedin an axial direction on one side of a needle shaft, and also providinga restoring force transverse to the axial direction on another side ofthe needle shaft in order to allow the needle received in the bore toextend all the way through the needle safety device while holding theneedle tip within the needle safety device as the needle is pulledthrough the needle safety device.
 18. The safety device of claim 17,wherein said elastic element acts alone in providing said restoringforce to the jaws during normal operation.
 19. The needle safety devicein accordance with claim 17, wherein the elastic element comprises atension ring or tension spring mounted to the jaws, respectively. 20.The needle safety device in accordance with claim 19, wherein thetension ring or tension spring is mounted to a mounting structureprovided on each of the jaws.
 21. The needle safety device in accordancewith claim 20, wherein the mounting structure comprises a projection, ahook, and/or a mounting recess.
 22. The needle safety device inaccordance with claim 17, wherein the elastic element comprises anelastic ring connected to extensions extending in a transverse axialdirection from a side of the jaws.
 23. The needle safety device inaccordance with claim 17, wherein at least one of the jaws has an angledend section at its free end, which extends towards the other one of thejaws in a direction generally perpendicular to the axial direction. 24.A needle safety device for a medical device, the needle safety devicecomprising: a base portion having a bore extending along a longitudinalcenter axis therethrough for receiving a needle having a needle tip anda needle shaft; an elastic element; and two opposing jaws extending fromthe base portion generally in the axial direction and each having a headportion in the region of its free end, wherein the needle safety deviceincludes a locking projection for securing the needle safety device tothe medical device, wherein the elastic element is connected to an endor to a projection extending from the end of one of the jaws, andfurther wherein the elastic element is connected to a portion underneathan end or to a projection extending from underneath an end of anotherone of the jaws, and still further wherein the elastic element and thejaws are configured such that the jaws are capable of being spread apartagainst a restoring force of the elastic element that is provided in anaxial direction on one side of the needle shaft, and also providing arestoring force transverse to the axial direction on another side of theneedle shaft in order to hold the needle tip within the needle safetydevice as the needle is pulled through the needle safety device.